MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MNTR OC PLATE SMALL; ORTHOSIS, SPINAL PEDICLE FIXATION

Catalog Number	188362031
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Not Applicable (3189)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Visual examination of the returned device showed witness marks which are evidence of usage.It was noted that the tabs of the plate were bent.The visual inspection also revealed that one of the screw tabs threads attached to the plate were torn.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.A definitive root cause for the threads being torn on one of the screw tabs attached to the mountaineer oc plate small cannot be determined.A potential root cause could be due to inadvertently cross-threading the set screw with the screw on the plate during the insertion and subsequent attempts to tighten the set screw, placing enough force on the threads to tear them off completely.A definitive root cause for the tabs of the plate becoming bent cannot be positively determined.However, noted damage suggest that the plate tab underwent an unanticipated loading, resulting in the tabs of the plate becoming bent.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
During occipit to c4 fusion with mountaineer, surgeon attempted to final tighten right side occipital set screw (188362025) on the occipital plate (188362031) and felt the final tightener (288314000) stripping the set screw.A countertorque and rod holder were used at the time of final tightening for stabilization.He could not get another oc set screw to engage with the plate again, and believed the rod capturing head on the plate was broken, or splayed.The set screw that stripped was inadvertently discarded.The surgeon had to remove all set screws and the rods in order to access the plate to remove it.It was replaced with the same size and another tray was opened for a second final tightener.It is suspected this was caused by an out-of-calibration final tightener.I am also requesting exchanges for all mountaineer final tighteners in an abundance of caution.

• Brand Name: MNTR OC PLATE SMALL
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9163101
• Report Number: 1526439-2019-52214
• Device Sequence Number: 2486882
• Product Code: MNI
• UDI-Device Identifier: 10705034158877
• UDI-Public: 10705034158877
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K042508
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 188362031
• Device Lot Number: WA2714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 10/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1