SPROTTERecalls & reported problems across all models
Pajunk GmbH Medizintechnologie · 32 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 59
- Deaths reported
- 0
- Injuries reported
- 19
- Recalls
- 0
We found 32 models of SPROTTE by Pajunk GmbH Medizintechnologie in the FDA's device registry (GUDID). Together they are named in 59 adverse event reports in the FDA's MAUDE database, received between Jul 18, 2017 and Jul 21, 2026 — classified as 19 injuries, 40 malfunctions.
The most frequently reported specific device problem is “Break” (31 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 SPROTTE problems
Device problems
- Break31
- Fracture14
- Loss of or Failure to Bond6
- Nonstandard Device5
- Device Handling Problem4
- Failure To Adhere Or Bond3
- No Flow3
- Detachment of Device or Device Component2
Patient problems
- Foreign Body In Patient24
- No Clinical Signs, Symptoms or Conditions19
- No Known Impact Or Consequence To Patient9
- No Consequences Or Impact To Patient7
- Device Embedded In Tissue or Plaque5
- Inadequate Pain Relief3
- Pain2
- Insufficient Information1
SPROTTE models
32 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SPROTTE® 021163-29ANEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)4 reports
- SPROTTE® 021151-29ANEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)4 reports
- SPROTTE® 121151-27ANEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)4 reports
- SPROTTE 041251-29ANEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)3 reports
- SPROTTE® 021251-29ANEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)3 reports
- SPROTTE® 211163-29ANEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)3 reports
- SPROTTE® 121151-30ANEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)3 reports
- SPROTTE® 021163-30ANEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)2 reports
- SPROTTE® 511151-29ANEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)2 reports
- SPROTTE® 121151-30ANEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)2 reports
- SPROTTE® 321151-31ANEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)2 reports
- SPROTTE® 021151-29ANEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)2 reports
- SPROTTE® 511151-29ANEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)2 reports
- SPROTTE® 001151-30ANEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)2 reports
- SPROTTE® 021151-30CNEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)2 reports
- SPROTTE® 041151-30ANEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)2 reports
- SPROTTE® 501151-29ANEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)2 reports
- SPROTTE® 021151-29ANEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 report
- SPROTTE® 021151-30ANEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 report
- SPROTTE® 121151-27ANEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 report
- SPROTTE® 141151-27ANEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 report
- SPROTTE® 141251-27ANEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 report
- SPROTTE® 021163-30CNEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 report
- SPROTTE® 021251-30ANEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 report
- SPROTTE® 051163-29ANEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 report
- SPROTTE® 121251-27ANEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 report
- SPROTTE® 131151-30CNEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 report
- SPROTTE® 121151-27ANEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 report
- SPROTTE® 001151-30CNEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 report
- SPROTTE® 071151-30ANEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 report
- SPROTTE® 131151-30CNEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 report
- SPROTTE® 511151-29ANEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 report
Recent SPROTTE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJul 21, 2026Break
IRN# (B)(4) THIS INCIDENT TOOK PLACE IN FRANCE. THE DEPARTMENT REPORTED AN INITIAL FAILURE OF THE LUMBAR PUNCTURE PROCEDURE USING A STANDARD INTRODUCER. THE LUMBAR. PUNCTURE WAS SUBSEQUENTLY PERFORMED USING A LONG ATRAUMATIC NEEDLE. DURING NEEDLE ADVANCEMENT, BONY CONTACT. OCCURRED. UPON WITHDRAWAL, THE NEEDLE FRACTURED AT ITS MIDPOINT, LEAVING A FRAGMENT IN SITU. THE PATIENT WAS TRANSFERRED TO THE NEURORADIOLOGY DEPARTMENT, WHERE AN INCISION WAS MADE TO REMOVE THE NEEDLE FRAGMENT UNDER FLUOROSCOPIC GUIDANCE. THE LUMBAR PUNCTURE WAS THEN SUCCESSFULLY COMPLETED UNDER FLUOROSCOPIC GUIDANCE. PAIN AT THE PUNCTURE SITE WAS REPORTED FOLLOWING THE PROCEDURE AND WAS RELIEVED BY THE ADMINISTRATION OF 1 G OF PARACETAMOL. NO OTHER COMPLICATIONS HAVE BEEN OBSERVED TO DATE. THE BROKEN NEEDLE FRAGMENT WAS SUCCESSFULLY REMOVED UNDER FLUOROSCOPIC GUIDANCE.
Patient problems: Foreign Body In Patient
MAUDE report 25885073 ↗InjuryJul 15, 2026Break
IRN# (B)(4). THIS INCIDENT TOOK PLACE IN FRANCE. 23-YEAR-OLD PATIENT HOSPITALIZED FOR INVESTIGATION OF INTRACRANIAL HYPERTENSION. AN ATTEMPT AT LUMBAR PUNCTURE WAS MADE ON (B)(6) 2026 WITH PREMEDICATION USING 20 MG OF SERESTA AND APPLICATION OF AN EMLA PATCH APPROXIMATELY 30 MINUTES BEFORE THE PROCEDURE. SKIN PREPARATION WAS PERFORMED WITH SOAP FOLLOWED BY CHLORHEXIDINE. A 24G VIOLET NEEDLE WAS USED. DESPITE A PROPERLY CONDUCTED PROCEDURE, IT WAS IMPOSSIBLE TO REACH THE VERTEBRAE (BMI: 39.96). THE NEEDLE WAS INSERTED ALMOST UP TO THE HUB, AND WITHDRAWAL OF THE STYLET PROVED DIFFICULT; IT WAS EVENTUALLY REMOVED, TWISTED AT ITS TIP. REMOVAL OF THE NEEDLE SHOWED THAT IT WAS SPLIT IN ITS DISTAL THIRD. A LUMBAR SPINE X-RAY WAS PERFORMED, CONFIRMING THAT A 6.62 MM FRAGMENT OF THE NEEDLE REMAINED AT THE LEVEL OF THE L4-L5 INTERSPINOUS SPACE. REMOVAL OF THE NEEDLE FRAGMENT WAS CARRIED OUT UNDER GENERAL ANESTHESIA BY A NEUROSURGEON ON (B)(6) 2026.
Patient problems: Foreign Body In Patient
MAUDE report 25824574 ↗InjuryApr 2, 2026Break
(B)(4). INCIDENT OCCURRED IN FRANCE. DURING SPINAL ANESTHESIA FOR A CESAREAN SECTION, THE NEEDLE BROKE JUST BEHIND THE BASE UPON CONTACT WITH A VERTEBRA. THE ANESTHESIOLOGIST REPORTED NO PRIOR DEFORMATION OR TWISTING OF THE NEEDLE. THE BREAK OCCURRED IMMEDIATELY. THE NEEDLE WAS REMOVED AND REPLACED. NO CLINICAL CONSEQUENCES FOR THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 24766260 ↗InjurySep 22, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IRN# (B)(4) INCIDENT OCCURED IN SWITZERLAND. ON (B)(6) 2025: SPROTTE LUMBAR IS BROKEN OFF ON (B)(6) 2025: UPDATE OF EVENT PROBLEM: PERFORMING A LUMBAR PUNCTURE ON A PATIENT WITH DEMENTIA (A.E. LEWY BODY).INDICATION: DETERMINATION OF DEMENTIA MARKERS. PATIENT IN LEFT LATERAL POSITION, AFTER MARKING THE PUNCTURE SITE AT THE LEVEL OF THE UPPER EDGE OF THE OS ILII, DISINFECTION AND STERILE DRAPING. THE ASSISTANT DOCTOR THEN INSERTS THE SPACER NEEDLE BETWEEN THE SPINOUS PROCESSES. AFTER A SLIGHT READJUSTMENT DUE TO RESISTANCE, THE NEEDLE CAN BE INSERTED AS FAR AS IT WILL GO. THREE UNSUCCESSFUL ATTEMPTS ARE MADE TO PUNCTURE WITH THE PUNCTURE NEEDLE THROUGH THE SPACER, WITH THE USUAL READJUSTMENT AFTER EACH ATTEMPT (THE SPACER REMAINS IN SITU THROUGHOUT). THEN THERE IS A CHANGE OF HANDS; THE PUNCTURE NEEDLE IS COMPLETELY WITHDRAWN FOR THIS PURPOSE, WHILE THE SPACER REMAINS IN SITU. WHEN REINSERTING THE NEEDLE THROUGH THE SPACER, THERE IS RESISTANCE; THE NEEDLE SEEMS TO RUB SLIGHTLY AGAINST THE SPACER. WITH A LITTLE MORE PRESSURE FROM THE PUNCTURE HAND, HOLDING THE BACK OF THE NEEDLE, THE RESISTANCE CAN BE OVERCOME AND 2-3 FURTHER UNSUCCESSFUL PUNCTURE ATTEMPTS ARE MADE. A DECISION IS THEN
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 23109510 ↗InjuryJul 18, 2025Break; Break
IRN# (B)(4) INCIDENT OCCURRED IN UK: PANJUNK SPROTTE 25X90MM NEEDLE BROKE WHILE PULLING OUT, HOWEVER ENTIRE NEEDLE COULD BE RETRIEVED.CONFIRMED BY -NOTING BEVEL AT DISTAL END, COMPARING LENGTH OF BROKEN PARTS WITH ANOTHER NEEDLE (90MM). REPORTER NOTES - "IDON'T THINK THERE WAS NOT ANY EXCESSIVE FORCE INVOLVED. JUST A ROUTINE SPINAL WITH MILD DIFFICULTY DUE TO HIGH BMI. THE NEEDLE BREAK IN SUCH CASE RAISES CONCERN. I DON'T THINK THINGS COULD HAVE BEEN DONE DIFFERENTLY FROM POINT OF VIEW OF TECHNIQUE, HUMAN FACTORS ETC" BMI 40+.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22539491 ↗MalfunctionJul 8, 2025Break; Break
IRN# (B)(4) INCIDENT OCCURRED IN ITALY. THE NEEDLE BROKE MORE OR LESS IN THE MIDDLE OF THE SHAFT AND ONE PART REMAINED TRAPPED IN THE BACK OF THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 22436796 ↗InjuryJul 8, 2025Break; Break
(B)(4). INCIDENT OCCURRED IN THE UK. PROBLEM WITH THE NEEDLE, WHEREBY THE FIRST 4.5 CM OF THE NEEDLE TIP BROKE (POTENTIALLY OFF THE INTRODUCER, WHILST CAUGHT ON THE TRANSVERSE PROCESS' VERTEBRAE. THE PATIENT HAS A VERY HIGH BMI.
Patient problems: Foreign Body In Patient
MAUDE report 22436795 ↗InjuryJul 8, 2025Break; Break
(B)(4). INCIDENT OCCURRED IN ITALY. DURING THE SPINAL ANESTHESIA PROCEDURE, THE NEEDLE DISTAL PORTION BROKE, ABOUT 3 CM IMMEDIATELY AFTER STARTING THE PROCEDURE.
Patient problems: Foreign Body In Patient
MAUDE report 22436793 ↗InjuryJul 8, 2025Break; Break
(B)(4). INCIDENT OCCURRED IN GERMANY. NEEDLE BROKEN AFTER BONE CONTACT.
Patient problems: Foreign Body In Patient
MAUDE report 22436792 ↗InjuryJul 8, 2025Break; Break
IRN# (B)(4) INCIDENT OCCURRED IN (B)(6). THE PATIENT IS IN LABOUR AND OPEN 9 CM AND ABOUT TO GET SPINAL ANESTHESIA. AT THE FIRST ATTEMPT THERE IS NO BACK SUCTION, AND WE TRY TO ADJUST BY PULLING THE NEEDLE OUT SLOWLY. A FAINT RESISTANCE AFTER ABOUT 5 MM AND THEN THE NEEDLE BREAKS IN TWO ABOUT 1 CM FROM THE INTRODUCER.
Patient problems: Foreign Body In Patient
MAUDE report 22436775 ↗InjuryJul 8, 2025Break; Break
IRN # (B)(4) INCIDENT OCCURRED IN FRANCE: DURING SPINAL ANAESTHESIA ON A PREGNANT WOMAN FOR A CAESAREAN SECTION, THE SPINAL NEEDLE BENT AND THEN BROKE. THE NEEDLE HAS BEEN REMOVED AND THE PATIENT DOESN'T HAVE ANY CONSEQUENCES.
Patient problems: Foreign Body In Patient
MAUDE report 22436773 ↗InjuryJul 2, 2025Break; Break
IRN# (B)(4). INCIDENT OCCURRED IN ITALY: WHILE REMOVING THE NEEDLE TO CHANGE POSITION, IT BROKE AND THE STUMP REMAINED INSIDE THE PATIENT, IMPOSSIBLE TO REMOVE WITH BARE HANDS (ABOUT 4.5CM). THEREFORE, THE PATIENT REQUIRED A DIAGNOSTIC-THERAPEUTIC PATHWAY, WHICH ENDED WITH THE REMOVAL OF THE STUMP BY THE NEUROSURGERY COLLEAGUES. NO NEUROLOGICAL DAMAGE WAS REPORTED IN THE PATIENT THROUGHOUT THE PERIPROCEDURAL PATHWAY.
Patient problems: Foreign Body In Patient
MAUDE report 22381699 ↗MalfunctionApr 30, 2025Break; Break
(B)(4). INCIDENT OCCURRED IN ITALY: DURING THE INSERTION OF THE INTRODUCER, AFTER AN INITIAL DIFFICULTY DUE TO AN OBSTACLE (POSSIBLY A CALCIFIED YELLOW LIGAMENT?), I WAS ABLE TO INSERT THE ENTIRE INTRODUCER WITHOUT DIFFICULTY. HOWEVER, I THEN ENCOUNTERED AN INABILITY TO ADVANCE THE INTRODUCER NEEDLE. UPON REMOVAL OF THE INTRODUCER, I FOUND THAT IT HAD BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21934418 ↗MalfunctionApr 23, 2025Disconnection; Disconnection
IRN# (B)(4). INCIDENT OCCURRED IN SWEDEN: THE NEEDLE CAME OFF/DISCONNECTED FROM THE CANNULA HOLDER, SEE ATTACHED PICTURE. THE NEEDLE REMAINED IN THE PATIENT, BARELY 1 CM OF THE NEEDLE WAS VISIBLE AT THAT TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21887853 ↗MalfunctionFeb 14, 2025Obstruction of Flow; Obstruction of Flow
IRN# (B)(4) INCIDENT OCCURRED IN GREAT BRITAIN: NEEDLE WAS USED ON A PATIENT BY AN ANAESTHETIST BUT WAS UNABLE TO INJECT DOWN THE NEEDLE. THE NEEDLE WAS REPOSITIONED THREE TIMES BUT HAD NO FLOW OF CSF WITH EACH ATTEMPT. THE NEEDLE WAS ASSUMED TO BE BLOCKED AND A NEW NEEDLE WAS USED FROM THE SAME BATCH. THE NEW NEEDLE HAD NO ISSUES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21382816 ↗
Other Pajunk GmbH Medizintechnologie products
All Pajunk GmbH Medizintechnologie 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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