SPINEMAPRecalls & reported problems across all models

We found 2 models of SPINEMAP by Stryker Leibinger GmbH & Co. KG in the FDA's device registry (GUDID). Together they are named in 58 adverse event reports in the FDA's MAUDE database, received between May 25, 2018 and Nov 5, 2024 — classified as 4 injuries, 54 malfunctions.

The most frequently reported specific device problem is “Imprecision” (29 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

Most reported SPINEMAP problems

SPINEMAP models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• SPINEMAP 6002-680-000

  Orthopedic stereotaxic instrument
  51 reports
• SPINEMAP 6002-670-000

  Orthopedic stereotaxic instrument
  7 reports

Recent SPINEMAP adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionNov 5, 2024Imprecision; Imprecision

  IT WAS REPORTED THAT DURING A CASE, THE NAVIGATION SYSTEM PRODUCED POOR QUALITY IMAGES THAT WERE UNABLE TO BE USED FOR SCREW PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20609983 ↗
• MalfunctionSep 4, 2024Imprecision; Imprecision

  IT WAS REPORTED THAT DURING A CASE USING THE SPINE MAP 3D 3.1 SOFTWARE, THE NAVIGATION WAS INACCURATE BY ABOUT 4-5 MILLIMETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20140367 ↗
• MalfunctionAug 29, 2024Imprecision; Imprecision

  IT WAS REPORTED THAT DURING A CASE USING THE SPINE MAP 3D 3.1 SOFTWARE, THE NAVIGATED GUIDE WAS INACCURATE WHICH RESULTED IN INCORRECT SCREW PLACEMENTS. THE SURGEON REPLACED 6 OUT OF THE 8 SCREWS WITH LARGER SIZED SCREWS TO CORRECT THE SCREW TRACT. THERE WAS A SURGICAL DELAY OF 180 MINUTES AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Spinal Column Injury

  MAUDE report 20100600 ↗
• InjuryJul 17, 2024Imprecision; Insufficient Device Problem Information; Imprecision; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT EXPERIENCED ARTERIAL BLEEDING DURING A NAVIGATED C1-C2 POSTERIOR FUSION CASE. THE SURGEON SUCCESSFULLY IMPLANTED NON-STRYKER SCREWS (DEPUY) ON THE LEFT SIDE. DURING PREPARATION FOR PLACEMENT OF THE RIGHT SIDE, NON-STRYKER C1 SCREW (DEPUY), THE SURGEON NOTED, " THE PATIENT STARTED TO BLEED." THE SPINOUS PROCESS CLAMP WAS REMOVED AND THE BLEEDING WAS STABILIZED. THE SURGEON THEN RE-REGISTERED THE PATIENT AND THE NAVIGATED DRILL GUIDE AND WAS SATISFIED WITH THE ACCURACY. THE SURGEON WAS ADVANCING THE DRILL A SECOND TIME AND THE PATIENT STARTED TO BLEED AGAIN. THE PROCEDURE WAS NOT COMPLETED AS PLANNED AND THE PATIENT RECEIVED A BLOOD TRANSFUSION. IT WAS REPORTED THAT AT THEIR 7 DAY POST OPERATIVE CHECK-UP, THE PATIENT WAS FINE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19767370 ↗
• MalfunctionJul 17, 2024Imprecision; Imprecision

  IT WAS REPORTED THAT, DURING REGISTRATION OF THE SPINEMAP 3D SOFTWARE, THE SYSTEM WAS INACCURATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19761219 ↗
• MalfunctionApr 25, 2024Imprecision; Incorrect Measurement; Imprecision; Incorrect Measurement

  IT WAS REPORTED THAT WHEN USING THE SPINE MAP 3D 3.1 SOFTWARE, THE ACCURACY WAS OFF BY 2-3 MILLIMETERS WHICH MADE NAVIGATION AND SCREW PLACEMENT DIFFICULT FOR THE SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19187723 ↗
• MalfunctionApr 25, 2024Imprecision; Incorrect Measurement; Imprecision; Incorrect Measurement

  IT WAS REPORTED THAT WHEN USING THE SPINE MAP 3D 3.1 SOFTWARE, THE ACCURACY WAS OFF BY 2-3 MILLIMETERS WHICH MADE NAVIGATION AND SCREW PLACEMENT DIFFICULT FOR THE SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19187714 ↗
• MalfunctionAug 10, 2023Incorrect Measurement; Incorrect Measurement

  PER THE CUSTOMER, THE DEVICE DISPLAY WAS "BOUNCING" DURING A PROCEDURE AND SHOWED DEVIATIONS UP TO 5 MM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17497239 ↗
• InjuryAug 3, 2023Incorrect Measurement; Incorrect Measurement

  PER THE CUSTOMER, THE SURGEON PLACED PEDICLE SCREWS IN A PATIENT WITH NAVIGATION. ONCE ALL SCREWS WERE PLACED, THE SURGEON REQUESTED ANOTHER SPIN TO CHECK SCREW POSITIONING. 4 OF THE 6 SCREWS WERE MALPOSITIONED, SO HE REMOVED ALL HARDWARE AND ABORTED THE CASE. THE PROCEDURE WAS RESCHEDULED FOR THE NEXT DAY AND COMPLETED SUCCESSFULLY, NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17451379 ↗
• MalfunctionAug 1, 2023Incorrect Measurement; Incorrect Measurement

  PER THE CUSTOMER, DURING THE AUTOMATIC REGISTRATION THE DEVICE WAS DEEMED INACCURATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17434331 ↗
• MalfunctionJul 25, 2023Incorrect Measurement; Incorrect Measurement

  PER THE CUSTOMER, THERE WERE INACCURACIES DURING THE CASE GREATER THAN 5MM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17393853 ↗
• MalfunctionJun 20, 2023Incorrect Measurement; Incorrect Measurement

  PER THE CUSTOMER WHILE NAVIGATING WITH THE DEVICE THE SURGEON COMPLAINED OF AN INACCURACY. PER THE SURGEON THE AWL¿S TIP AND KWIC NEEDLE SEEMED PUNCTURED IN BONE WHILE OTHERS POINTER DID NOT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17165247 ↗
• MalfunctionJun 7, 2023Incorrect Measurement; Incorrect Measurement

  PER THE CUSTOMER, WHILE PERFORMING MIS FUSION CASE THE NAV LOCKED GEAR SHIFT WAS INACCURATE. THE DEVICE SHOWED THAT THE INSTRUMENT WAS DIRECTLY DOWN THE PEDICLE, HOWEVER FLUORO SHOWED THE INSTRUMENT LATERAL WITH NO PART OF IT IN BONE. AFTER RECALIBRATING, THE INSTRUMENTS ACCURACY WAS BETTER BUT SOON LOST ACCURACY AFTER BEING PROGRESSED DOWN THE PEDICLE. WITHIN THE SAME SCREW HOLE, THE SURGEON WOULD ROTATE THE INSTRUMENT AND DEPENDING ON WHICH SIDE THE TRACKER WAS MOVED, IT WOULD SHOW THE INSTRUMENT IN TWO COMPLETELY DIFFERENT LOCATIONS (BOTH OF WHICH WERE INACCURATE). THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17079234 ↗
• MalfunctionApr 5, 2023Incorrect Measurement; Incorrect Measurement

  PER THE CUSTOMER, DURING A L5/S1 FIXATION WITH NAVIGATION AFTER POSITIONING ALL 4 SCREWS WITH NAVIGATION AND HAVING TAKEN FINAL IMAGE ACQUISITION NOTICED ONE OF THE SCREWS (RIGHT L5) APPEARED TO BE MORE LATERAL THAN IT SHOWED WHEN PLACING THE SCREW WITH NAVIGATION. THE SCREW WAS REPOSITIONED WITH X-RAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16682536 ↗
• MalfunctionMar 22, 2023Incorrect Measurement; Incorrect Measurement

  PER THE CUSTOMER, DURING A POSTERIOR LUMBAR FUSION USING NAV3I AND ZIEHM, THE SURGEON COMPLAINED OF INACCURACY. AFTER CONDUCTING THE FIRST SPIN (0.33MM AUTOMATIC REGISTRATION DEVIATION) AND COMPLETING THE RIGHT SIDE WITH KWIRES THE SURGEON MOVED TO THE LEFT SIDE, AND COMPLAINED THAT "ACCURACY WAS OFF." THE CUSTOMER ATTRIBUTED THE NGENIUS TRACKER (ON ORTHOPINS) AS POTENTIALLY BEING "BUMPED." A SECOND SPIN (0.50MM DEVIATION) WAS CONDUCTED AND 6 SCREWS WERE PLACED IN THE PATIENT. THE SURGEON WAS STILL UNSURE OF ACCURACY, SO THREE STAPLES WERE PLACED IN THE PATIENTS BACK WITHIN THE SCAN CENTER AND A THIRD SPIN WAS CONDUCTED (0.43MM DEVIATION). AFTER CONDUCTING THE SPIN AND REMOVING THE Z-DRAPE, ACCURACY WAS CHECKED WITH THE LONG POINTER DOWN THE CENTER OF ONE OF THE SCREW TULIPS AND TOUCHING ON THE STAPLES, THERE STILL APPEARED TO BE INACCURACY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16589495 ↗

Other Stryker Leibinger GmbH & Co. KG products

• Direct Inject3 models · 16 reports · 1 recall
• SMARTLOCK17 models · 64 reports
• MEDPOR TITAN5 models · 6 reports · 1 recall
• MEDPOR25 models · 49 reports