MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MNTR LS SCREW 3.5X20; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Model Number	188320320
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Not Applicable (3189)
Date of Event	03/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.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
It was reported after implanting all screws and rods, (b)(6) was final tightening the outer nut for the crosslink and it pulled the inner set screw out of the screw head.He thought it was a defective set screw so he changed out the inner set screw.When he put on the outer nut and started to final tighten it, it pulled out the inner set screw again.He tried this again with the same outcome.At this point he examined the threads in the screw head and realized that the threads were gone on one side of the tulip.He then had to remove the rod and change out the actual screw.After changing out the screw, everything locked down as it should.30 minute delay reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Visual examination of the returned device found that the initial threads on the screw¿s tulip head had become torn off.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.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.A definitive root cause for the tulip head threads becoming torn off cannot be positively determined.However, the noted damage suggests that inadvertently cross threading of the set screw occurred upon insertion into the tulip head.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 and no systemic trends were found, 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.

• Brand Name: MNTR LS SCREW 3.5X20
• Common Device Name: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 7450888
• Report Number: 1526439-2018-50394
• Device Sequence Number: 10791549
• Product Code: NKG
• UDI-Device Identifier: 10705034158105
• UDI-Public: (01)10705034158105
• Combination Product (Y/N): N
• PMA/510(K) Number: K041203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2018

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 Model Number: 188320320
• Device Catalogue Number: 188320320
• Device Lot Number: 103005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2018
• Initial Date Received by Manufacturer: 03/26/2018
• Supplement Date Received by Manufacturer: 05/16/2018
• Initial Report FDA Received Date: 04/23/2018
• Supplement Report FDA Received Date: 05/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR