Cannulated Compression Headless ScrewRecalls & reported problems across all models
Tyber Medical, LLC · 21 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 27
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls
- 0
We found 21 models of Cannulated Compression Headless Screw by Tyber Medical, LLC in the FDA's device registry (GUDID). Together they are named in 27 adverse event reports in the FDA's MAUDE database, received between May 29, 2020 and Aug 14, 2025 — classified as 8 injuries, 19 malfunctions.
The most frequently reported specific device problem is “Fracture” (9 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Cannulated Compression Headless Screw problems
Device problems
- Fracture9
- Adverse Event Without Identified Device or Use Problem4
- Failure to Osseointegrate3
- Insufficient Device Problem Information3
- Loosening of Implant Not Related to Bone-Ingrowth3
- Break2
- Expulsion1
- Failure to Align1
Patient problems
- Nonunion/Delayed-union Bone Fracture11
- Insufficient Information6
- No Clinical Signs, Symptoms or Conditions5
- Implant Pain4
- Radiolucent Lines4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Failure of Implant1
- Foreign Body In Patient1
Cannulated Compression Headless Screw models
21 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Cannulated Compression Headless Screw 04.333.124TSScrew, fixation, bone3 reports
- Cannulated Compression Headless Screw 04.334.240Screw, fixation, bone2 reports
- Cannulated Compression Headless Screw 04.334.440Screw, fixation, bone2 reports
- Cannulated Compression Headless Screw 04.333.765Screw, fixation, bone2 reports
- Cannulated Compression Headless Screw 04.333.226TSScrew, fixation, bone2 reports
- Cannulated Compression Headless Screw 04.334.028Screw, fixation, bone1 report
- Cannulated Compression Headless Screw 04.334.444Screw, fixation, bone1 report
- Cannulated Compression Headless Screw 04.333.530Screw, fixation, bone1 report
- Cannulated Compression Headless Screw 04.334.502Screw, fixation, bone1 report
- Cannulated Compression Headless Screw 04.333.642Screw, fixation, bone1 report
- Cannulated Compression Headless Screw 04.333.650Screw, fixation, bone1 report
- Cannulated Compression Headless Screw 04.334.655Screw, fixation, bone1 report
- Cannulated Compression Headless Screw 04.334.660Screw, fixation, bone1 report
- Cannulated Compression Headless Screw 04.333.750Screw, fixation, bone1 report
- Cannulated Compression Headless Screw 04.334.750Screw, fixation, bone1 report
- Cannulated Compression Headless Screw 03.333.101ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- Cannulated Compression Headless Screw 03.333.300Orthopedic manual surgical instrument1 report
- Cannulated Compression Headless Screw 03.333.302Orthopedic manual surgical instrument1 report
- Cannulated Compression Headless Screw 04.334.026TSScrew, fixation, bone1 report
- Cannulated Compression Headless Screw 04.333.224TSScrew, fixation, bone1 report
- Cannulated Compression Headless Screw 04.334.454TSScrew, fixation, bone1 report
Recent Cannulated Compression Headless Screw adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 14, 2025Fracture; Fracture
IT WAS REPORTED THAT ON (B)(6) 2025 WHILE DRILLING THROUGH THE 1ST MET, RESIDENT DOCTOR MENTIONED THAT THERE WASN'T FEELING LIKE THERE WAS MUCH POWER OR ANY ADVANCEMENTS WITH THE DRILL BIT. THE SURGEON ASSUMED IT WAS DUE TO THE NATURE OF THE PATIENT'S HARDER THAN AVERAGE BONE AS THE SURGEON HAD ALREADY GONE THROUGH 3 SAW BLADES PRIOR TO THIS INCIDENT. UPON PULLING THE DRILL BIT OUT OF THE TISSUE SLEEVE, THE RESIDENT NOTICED THE DRILL BIT HAD SNAPPED. UPON FLUORO, IT WAS DISCOVERED THAT THE TIP OF THE DRILL BIT HAD SNAPPED INTO ONE LARGE PIECE, AND 2 SMALLER PIECES WHILE ALSO DAMAGING THE DRILL SLEEVE WHEN PULLING OUT. THE SURGEON WAS ABLE TO REMOVE THE LARGE PIECE OF THE DRILL BIT BUT WAS UNABLE TO RECOVER THE 2 SMALLER FRAGMENTS THAT WERE STUCK WITHIN THE BONE/OSTEOTOMY SITE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22811861 ↗MalfunctionJun 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
AS REPORTED BY THE COMPLAINANT: CASE INVOLVES A 12-YEAR-OLD GIRL WITH A PSEUDOARTHROSIS. FORTUNATELY, THE PSEUDOARTHROSIS HAS CONSOLIDATED, SO THE SCREW CAN BE REMOVED IN THE NEAR FUTURE. THE SURGERY TOOK PLACE ON 16/01/25. THE CONTROL PHOTOS HAVE THE DATE VISIBLE, BUT HERE TOO, THERE'S A MORE OR LESS IMMEDIATE FAILURE. THE PSEUDOARTHROSIS HAS CONSOLIDATED, AND THE SCREW WILL BE REMOVED SOON, WITH NO REVISION REQUIRED.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 22350832 ↗MalfunctionJun 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
AS REPORTED BY THE COMPLAINANT: PRIMARY FIXATION IN A HEALTHY MAN. SURGERY SCHEDULED ON (B)(6) 2024, PRIMARY FIXATION, WITH ALMOST IMMEDIATE FAILURE. THE PATIENT HAS SINCE THEN UNDERGONE A REVISION WITH A PLATE, BUT THIS TOO HAS FAILED. THE PATIENT IS NOW REFERRED TO A DIFFERENT FACILITY AND OTHER CARE. IMPLANT REVISION SURGERY HAS BEEN REPORTED.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 22350831 ↗MalfunctionJun 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
AS REPORTED BY THE COMPLAINANT: THIS SCREW IS EXPECTED TO COME OUT OF THE SCAPHOID IN THE NEAR FUTURE. PSEUDOARTHROSIS IN A LIGHT SMOKER (5 CIGARETTES DAILY) CT REGARDING PSEUDOARTHROSIS CONSOLIDATION ISN'T LOOKING GOOD BASED ON THE IMAGES.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 22350830 ↗InjuryFeb 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE FOLLOWING ADVERSE EVENT WAS DISCOVERED AS PART OF A RETROSPECTIVE CLINICAL TRIAL: PATIENT HAD A CT SCAN PERFORMED ON (B)(6) 2023 CONFIRMED NON-UNION. PT WAS RX'D A BONE STIMULATOR TO BEGIN USING DAILY. HE HAD ANOTHER CT SCAN DONE ON (B)(6) 2023 WITH CONTINUED NON-UNION. HE CONTINUED USING BONE STIMULATOR AND BRACE UNTIL HE WAS CLEARED FOR SURGICAL CORRECTION ON (B)(6) 2024 (18 MONTHS POST OP). THE EVENT WAS CONTINUOUS, HAD SEVERE SYMPTOMS, WAS NOT SERIOUS, HAD A PROBABLE RELATIONSHIP TO THE STUDY DEVICE, AND HOSPITALIZATION WAS REQUIRED. THE SUBJECT RECOVERED WITHOUT SEQUELAE.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 21472733 ↗MalfunctionFeb 19, 2025Fracture; Fracture
ADVERSE EVENT CAPTURED AS PART OF A RETROSPECTIVE CLINICAL STUDY: AT 2 MONTHS POST OPERATIVE, ONE SCREW WAS NOTED TO BE BROKEN. AT 3 MONTHS POST OPERATIVE A SECOND SCREW WAS NOTED TO BE BROKEN AS WELL. FOOT WAS STILL CONSIDERED STABLE AT THIS TIME. PATIENT LATER UNDERWENT HARDWARE REMOVAL OF THE BROKEN SCREWS AT 1 YEAR POST OP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21411949 ↗MalfunctionOct 21, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
ADVERSE EVENT FROM THE CLINICAL STUDY: AT 9-MONTHS POST-OPERATIVE IMAGING DEMONSTRATED SCREW LOOSE, RADIOLUCENCY; THE SUBJECT WAS ORDERED A BONE GROWTH STIMULATOR AND TOE-OFF BRACE. AT 11-MONTHS POST-OPERATIVE SUBJECT CONTINUED TO HAVE PAIN WITH AMBULATION AND PLANNED TO CONTINUE TO USE BONE GROWTH STIMULATOR AND SIMULTANEOUSLY SCHEDULE SURGERY TO HAVE HARDWARE REMOVED IF NO IMPROVEMENT IS SEEN WITH BONE GROWTH STIMULATOR; IMAGING DEMONSTRATED THAT THE RADIOLUCENCY REMAINED VISIBLE HOWEVER NO NEW SIGNS OF LOOSENING. AT 12-MONTHS POST-OPERATIVE SUBJECT CONTINUED TO USE BONE GROWTH STIMULATOR WITH NO SIGNS OF INCREASED HEALING; IMAGING SHOWS RADIOLUCENCY REMAINED PRESENT. AT 13.5-MONTHS POST-OPERATIVE SUBJECT UNDERWENT HARDWARE REMOVAL SURGERY DUE TO THE NONUNION. ALL HARDWARE WAS REMOVED DURING THE PROCEDURE AND WAS REPLACED WITH A DIFFERENT BRAND'S SYSTEM. SUBJECT WAS TERMINATED FROM THE STUDY UPON REMOVAL OF HEADLESS SCREWS.
Patient problems: Implant Pain; Nonunion/Delayed-union Bone Fracture; Radiolucent Lines
MAUDE report 20500212 ↗MalfunctionOct 21, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
THIS SUBMISSION IS FOR THE SECOND DEVICE ASSOCIATED WITH 3012966183-2024-00018. ADVERSE EVENT FROM THE CLINICAL STUDY: AT 9-MONTHS POST-OPERATIVE IMAGING DEMONSTRATED SCREW LOOSE, RADIOLUCENCY; THE SUBJECT WAS ORDERED A BONE GROWTH STIMULATOR AND TOE-OFF BRACE. AT 11-MONTHS POST-OPERATIVE SUBJECT CONTINUED TO HAVE PAIN WITH AMBULATION AND PLANNED TO CONTINUE TO USE BONE GROWTH STIMULATOR AND SIMULTANEOUSLY SCHEDULE SURGERY TO HAVE HARDWARE REMOVED IF NO IMPROVEMENT IS SEEN WITH BONE GROWTH STIMULATOR; IMAGING DEMONSTRATED THAT THE RADIOLUCENCY REMAINED VISIBLE HOWEVER NO NEW SIGNS OF LOOSENING. AT 12- MONTHS POST-OPERATIVE SUBJECT CONTINUED TO USE BONE GROWTH STIMULATOR WITH NO SIGNS OF INCREASED HEALING; IMAGING SHOWS RADIOLUCENCY REMAINED PRESENT. AT 13.5-MONTHS POST-OPERATIVE SUBJECT UNDERWENT HARDWARE REMOVAL SURGERY DUE TO THE NONUNION. ALL HARDWARE WAS REMOVED DURING THE PROCEDURE AND WAS REPLACED WITH A DIFFERENT BRAND'S SYSTEM. SUBJECT WAS TERMINATED FROM THE STUDY UPON REMOVAL OF HEADLESS SCREWS.
Patient problems: Implant Pain; Nonunion/Delayed-union Bone Fracture; Radiolucent Lines
MAUDE report 20498367 ↗MalfunctionOct 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DETAILS FROM CLINICAL STUDY: AT 6 MONTHS POST-OPERATIVE, IT WAS NOTED THAT "SCREW LOOSE; RADIOLUCENCY". THE SUBJECT DID NOT HAVE THE ABILITY TO WALK/PERFORM ACTIVITIES OF DAILY LIVING WITHOUT PAIN. THE SUBJECT WAS INSTRUCTED TO CONTINUE USING THE BONE GROWTH STIMULATOR FOR THE NEXT 6-WEEKS AND RETURN FOR FOLLOW-UP. SUBJECT WAS LOST TO FOLLOW-UP AFTER THE 6-MONTH POST-OPERATIVE VISIT. UNKNOWN IF SUBJECT RETURNED TO NORMAL ACTIVITY OR RECEIVED ADDITIONAL TREATMENT REGARDING THE LUCENCY. AT THE FINAL CLINIC VISIT THE SUBJECT WAS ADVISED TO RESTRICT WEIGHT BEARING AND CONTINUE TO USE BOOT AND CRUTCHES; SUBJECT CANCELLED FOLLOW-UP VISITS. SUBJECT WAS LOST TO FOLLOW-UP AFTER THE 6-MONTH POSTOPERATIVE VISIT. UNKNOWN IF SUBJECT RETURNED TO NORMAL ACTIVITY OR RECEIVED ADDITIONAL TREATMENT.
Patient problems: Implant Pain; Nonunion/Delayed-union Bone Fracture; Radiolucent Lines
MAUDE report 20493245 ↗InjuryOct 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
FROM CLINICAL INVESTIGATION: AT 19-MONTHS POST-OPERATIVE THE SUBJECT SLIPPED IN THE SHOWER AND PRESENTED TO THE CLINIC WITH A PROBABLE ANTERIOR TALOFIBULAR LIGAMENT SPRAIN WITH QUESTIONABLE SYMPTOMATIC NONUNION OF THE SUBTALAR JOINT. THE SUBJECT WAS PLACED BACK IN A FRACTURE BOOT DURING THE VISIT. AT 23.5 MONTHS POST-OPERATIVE A CT SCAN WAS OBTAINED WHERE NONUNION WAS CONFIRMED. THE SUBJECT HAD THE DEVICES REMOVED 23.5 MONTHS POST-OPERATIVE AND REPLACED WITH OTHER HARDWARE. SUBJECT WAS TERMINATED FROM THE STUDY AFTER HARDWARE REMOVAL.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 20486422 ↗InjuryOct 18, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
PER CLINICAL STUDY REPORT: AT 4-MONTHS POST-OPERATIVE THE PATIENT WAS NOT FUSED AND WAS DEEMED TO HAVE A PAINFUL NONUNION WITH THE SCREWS LOOSE AND RADIOLUCENCY AROUND THE SCREWS. AT 5-MONTHS POST-OPERATIVE THE SUBJECT HAD REVISION SURGERY TO REMOVE THE CCHS SCREWS: AN ANKLE ARTHRODESIS WITH AN ANTERIOR APPROACH WAS PERFORMED USING AN EFFUSION PLATE AND BONE GRAFT. TO REMOVE THE CCHS SCREWS: AN ANKLE ARTHRODESIS WITH AN ANTERIOR APPROACH WAS PERFORMED USING AN EFFUSION PLATE AND BONE GRAFT. SUBJECT WAS TERMINATED FROM THE STUDY UPON REMOVAL OF HEADLESS SCREWS.
Patient problems: Implant Pain; Nonunion/Delayed-union Bone Fracture; Radiolucent Lines
MAUDE report 20485618 ↗MalfunctionJul 17, 2024Fracture; Fracture
REPORTED FROM CUSTOMER: PROCEDURE: FOOT SURGERY. IT WAS REPORTED THAT ON (B)(6) 2024 5.5MM CCHS 50MM SCREW BROKE DURING INSERTION. SURGERY WAS COMPLETED SUCCESSFULLY WITH 30 MINS OF SURGICAL DELAY. PART OF THE BROKEN SCREW WAS REMOVED AND THE SURGEON BONE GRAFTED THE FRACTURE SITE. FRAGMENTS WERE GENERATED. PATIENT OUTCOME WAS UNKNOWN. THE SCREW WAS BROKEN IN TO 3 PIECES AND 2 OF THE PIECES WERE RETAINED. 5.5MM CCHS 50MM SCREW BROKE DURING INSERTION: WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? YES. IF YES, NUMBER OF MINUTES: 30 MIN. ACTION TAKEN WHEN EVENT OCCURRED? PART OF THE BROKEN SCREW WAS REMOVED AND THE SURGEON BONE GRAFTED THE FRACTURE SITE. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? YES. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? NO. PATIENT STATUS/ OUTCOME / CONSEQUENCES: PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? NOT AT THIS TIME. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY? UNKNOWN. TYBER MEDICAL RETRIEVED ADDITIONAL INFORMATION FR
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19760449 ↗MalfunctionMar 18, 2024Material Deformation; Material Deformation
2.0 MM CCHS SCREW BROKE WHILE INSERTING. THIS HAPPENED TWICE DURING THE SURGERY WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? --> YES,. ACTION TAKEN WHEN EVENT OCCURRED? --> SECOND SCREW INSERTED AND THE REMOVED. THIRD SCREW INSERTED SUCCESSFULLY. WAS PROCEDURE SUCCESSFULLY COMPLETED? --> YES. WERE FRAGMENTS GENERATED? --> UNKNOWN. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? --> NO. IF NO, EXPLAIN: --> THEY HAD TO USE BROKEN SCREW REMOVAL DEVICE. PATIENT STATUS/ OUTCOME / CONSEQUENCES -->. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY --> UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18926707 ↗InjuryDec 11, 2023Fracture; Fracture
IT WAS REPORTED THAT ON (B)(6) 2023, 4.5 TI CCHS SCREW, 110MM LT WAS BROKEN IN THE SHAFT DURING RETROGRADE INSERTION FOR DISTAL FIBULA FRACTURE FIXATION. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 18301248 ↗MalfunctionNov 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT DID NOT DEVELOP A SURGICAL SITE INFECTION. HE HAD SOME DELAYED WOUND HEALING RELATED TO THAT TWO CCHS IMPLANTS WERE IMPLANTED, RECEIVED ON THROUGH (B)(4).DR (B)(6) STATED THAT THE PATIENT WAS CURRENTLY HAPPY AND WOULD SEE HIM AGAIN IN 4 WEEKS. IF REVISION SURGERY IS HAPPY, DR (B)(6) WILL REMOVE DRILL FRAGMENT AT THAT TIME. IF NOT, HE HAS STATED THAT HE WILL LEAVE IT WHERE IT IS. X-RAY REVEALED: SCREW HAS MIGRATED SLIGHTLY AND DRILL BIT FRAGMENT IDENTIFIED. THE FRAGMENTS GENERATED ARE FROM AN UNKNOWN DRILL DEVICE NOT MADE AT TYBER MEDICAL.
Patient problems: Insufficient Information
MAUDE report 18228801 ↗
Other Tyber Medical, LLC products
All Tyber Medical, LLC devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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